UNIVERSITY RESEARCH ETHICS COMMITTEES IN THE UNITED KINGDOM Practice, Procedure and Governance David Anderson-Ford Chair, Brunel University Research Ethics Committee Chair Elect Association of Research Ethics Committees 2008
The main purpose of the University-wide policies and procedures concerning Research Ethics, is to achieve a balance between safeguarding the dignity and rights of the research participant and providing a supportive and protective ethical environment within which the university researcher can seek to further the boundaries of human knowledge. That environment must include the physiological, psychological, social, political, religious, cultural and economic consequences of the research for the participants. David Anderson-Ford Brunel University
Why the Concern? Dissatisfaction with the quality of ethical discussion in some research proposals Increasing incentives for less experienced researchers to carry out research Changing expectations - rights Need for explicit discussion of fundamental matters of ethical concern The issue of accountability Implications of new legislation Proliferation of small research projects
Regulation of Research Human Subjects Nuremberg Code 1945; Declaration of Helsinki 1964 (onwards) Drug testing Medicines Act 1968 Local Research Ethics Committees (1991) Multi-Centre Research Ethics Committees (1997) North Staffordshire Inquiry (2000) Alder Hey (2001/2)
Central Office for Research Ethics Committees (2001) EU Directive on Good Clinical Practice in Clinical Trials (2001) Research Governance Framework for Health and Social Care (DoH( 2001/2005) Requiring, inter alia: Social Care Research Ethics Committees (Local Authorities) University Research Ethics Committees
Different Dimensions Medical/Health Care/Social Care/Social Sciences Nature and type of non-medical research involving human participants Ethical issues re. social scientists less guidance: fewer review requirements Concern particularly in relation to vulnerable populations The work of the British Sociological Association; Social Research Association; British Psychological Society Government Chief Social Researcher s s Office ESRC Research Ethics Framework 2005
Recent Updates The Doyal Committee 2004 Lord Warner Department of Health Ad-hoc Advisory Group Report May 2005 ESRC Framework for Ethical Guidance re. Social Sciences 2005 (implement 2006) Cabinet Office Ethics Review 2007 Council for Industry and Higher Education: Ethical Issues in Higher Education 2006
Principles of Ethics 5 Principles: The Value of Life Goodness or Rightness Do no harm: - beneficence - non-malefeasance - malefeasance Justice or Fairness Truth-telling telling or Honesty Individual Freedom autonomy/capacity
Principles and issues Consent Confidentiality Data Protection Vulnerable Groups Risk Assessment
University Research Ethics Committees No agreed Standard Operating Procedures Debate re: central and/or devolved committees Accountability and responsiveness to the University
UREC Documentation University Code of Research Ethics University Handbook Code of Good Research Conduct Ethics Framework Code University Application Forms Full/Expedited Question Specific Guidance Template procedural documentation School Procedures
The Devolved System The School Research Ethics Officer The School Research Ethics Committee The School Review and Approval System Accountability to the Central Committee
BRUNEL UNIVERSITY RESEARCH ETHICS COMMITTEE Membership Terms of Reference School Procedures Role of the UREC in Relation to Individual School Procedures The NRES Form/Local Authority Form? The Review Process
QUALITY ASSURANCE Staff Development Supervision and Monitoring Curriculum Development Accreditation
Postscript UK Universities Research Ethics Committee Working Group Brunel University Joint Convenors with Kings College London Association of Research Ethics Committees
Research Governance setting standards; defining mechanisms for delivering standards; monitoring and assessing arrangements; improving research quality and safeguarding the public (by enhancing ethical and scientific quality, promoting good practice, reducing adverse incidents, ensuring that lessons are learned and preventing poor performance and misconduct (DH, 2005).